The invention relates to a device for connecting a closed receptacle and a container. The invention also relates to a ready-for-use set comprising, inter alia, a closed receptacle and a connection device of the afore-mentioned type.
In the domain of drug-packaging, it is known to store a component of a medicinal preparation, such as for example its active ingredient, in a recipient closed by a stopper of relatively non-rigid material, for example of elastomer. A liquid may be introduced into this recipient after perforation of the stopper in order to dissolve the component contained in the recipient or place it in suspension, with a view to obtaining a medicinal preparation in liquid form ready to be administered to the patient.
Document WO-A-97110156 discloses a connection device of the afore-mentioned type which comprises a base adapted to cover the neck of the recipient and extends in a flange forming an inner bore while a plunger is adapted to slide in this bore, between a position disengaged with respect to the stopper and a transfer position in which a hollow needle borne by the plunger traverses this stopper. The displacement of the plunger from its disengaged position towards its transfer position is effected manually by an operator. During this manipulation, it happens that the operator exerts on the flange for guiding the plunger or on the latter in the course of displacement, a transverse effort which may result in a perforation of the stopper in an inclined direction with respect to a central axis of symmetry of the stopper. The functional clearance between the plunger and the inner bore of the base cannot be reduced too significantly in order to allow a better axial guiding of the plunger, as the effort resisting the displacement of the plunger would in that case be too great. The risk of an inclined or xe2x80x9cslantwisexe2x80x9d perforation of the stopper is therefore non-negligible, in particular when the user has to prepare a medicament urgently.
The consequence of a slantwise perforation of the stopper is that the apparent section of the orifice, created in the stopper by the passage of the hollow needle, is greater than the outer diameter of this needle, to such an extent that leakages may be produced through the stopper, around the hollow needle. In particular, when the recipient and the container with which it is associated are placed in a position of flow by gravity of the reconstituted medicament from the recipient towards the container, i.e. when the recipient is placed above the container, it is possible that the medicinal preparation flows from the recipient towards the plunger and flows over the user""s hands, which may be dangerous for certain medicaments or unpleasant for less aggressive medicaments.
It is a more particular object of the invention to overcome these drawbacks by proposing an improvement in the known systems which allow their tightness to be guaranteed, including in the case of slantwise perforation of the stopper that they comprise.
The device of the invention is characterized in that it comprises a sealing lip arranged on an internal surface of the bore opposite the plunger or on a surface of the plunger, this lip being shaped to be in tight abutment against the plunger or against an internal surface of the bore, in the transfer position of the plunger.
Thanks to the invention, there is created a volume of containment around the hollow needle, between the plunger and the internal surface of the bore, this volume of containment making it possible to retain liquid possibly leaking outside the recipient through the orifice formed in the stopper by the hollow needle.
According to a first, advantageous variant embodiment of the invention, the base comprises a wall bearing against an outer part of the stopper, the lip being shaped on a face of this wall oriented towards the plunger. According to a second, advantageous variant embodiment, the lip is shaped on a front face of the plunger oriented towards the stopper. According to another advantageous variant embodiment, the lip is shaped on an inner radial surface of the flange or on an outer radial surface of the plunger.
In any case, the lip may be provided to present, in transverse section, an asymmetrical profile inducing a privileged direction of deformation. This aspect of the invention guarantees an adequate positioning of the lip when the plunger is in transfer position, this adequate positioning guaranteeing the desired seal.
According to another advantageous aspect of the invention, the flange bears, on its inner radial face, a circular ring adapted to cooperate with a corresponding shoulder of the outer radial surface of the plunger in order to lock this plunger in the transfer position. Locking of the plunger has the effect of precisely fixing the position of the plunger and consequently the crushing or deformation of the sealing lip, which ensures a tight contact between the lip and the surface with which it must cooperate. The ring may be provided to present an asymmetrical tranverse section, the face of the ring oriented towards the opening of the bore being less inclined with respect to the inner radial surface of the flange than the face of the ring oriented towards the stopper. This arrangement allows the ring not, or hardly, to hinder the movement of slide of the plunger in the direction of the stopper, from its disengaged position towards its transfer position, while it may efficiently oppose a movement of the plunger in the opposite direction. The ring is advantageously adapted to separate an annular volume defined in the bore around the front part of the plunger in transfer position, in tight manner from the ambient atmosphere. In that case, the ring performs a function of seal which is added to that of the lip mentioned hereinbefore.
The invention also relates to a ready-for-use assembly comprising a closed recipient containing a product, this recipient comprising a neck whose opening is obturated by a stopper made of relatively non-rigid material, and a connection device as described hereinabove, mounted on the recipient. Such an assembly makes it possible to conserve a component of a medicament, such as its active ingredient, sterile, and to prepare it when required by mixture with a liquid, without risk of dangerous or unpleasant leakage.